Cardio Notes: Analysis Knocks PFO Closure

A meta-analysis of three trials of patent foramen ovale (PFO) closure confirms a previous pooled analysis that found no benefit to using the devices versus medical therapy. Also, an ultrasound contrast agent is cleared of pulmonary hemodynamic effects.

Pooled Results Don't Back PFO Closure

A meta-analysis of three trials pitting PFO closure versus medical therapy for preventing recurrent cryptogenic stroke or transient ischemic attack (TIA) failed to show a significant difference between the two approaches.

George Ntaios, MD, of the University of Thessaly in Larissa, Greece, and colleagues pooled results from the 2,303 patients involved in the PC and RESPECT trials that used the Amplatzer PFO occluder and the CLOSURE-I trial that used the STARFlex device.

In a subgroup analysis, the Amplatzer PFO occluder -- but not the STARFlex device -- was better than medical therapy at reducing ischemic stroke (1.4% versus 3.04%, OR 0.46, 95% CI 0.21-0.98). In addition, the rate of new-onset atrial fibrillation was increased with the STARFlex device but not with the Amplatzer occluder.

"This meta-analysis does not support PFO closure for secondary prevention with unselected devices in cryptogenic stroke/TIA," the authors wrote, adding that the subgroup analysis showing some benefit for the Amplatzer device "should be confirmed in further trials using inclusion criteria for patients with high likelihood of PFO-related stroke recurrence."

No Negative Pulmonary Hemodynamic Effects With Microsphere

In a post-marketing study mandated by the FDA, the ultrasound contrast agent Optison did not have adverse effects on pulmonary artery systolic pressure or pulmonary vascular resistance.

The safety of ultrasound contrast agents was called into question in 2007 following reports of deaths and serious adverse events with their use, which prompted the FDA to place a boxed warning on the labels of the products available at the time, Optison and Definity. The following year, the FDA requested a series of post-marketing studies, including one looking at effects on pulmonary hemodynamics.

Michael Main, MD, of Saint Luke's Mid American Heart Institute in Kansas City, Mo., and colleagues reported the results of that study in the American Journal of Cardiology. The placebo-controlled, crossover study included 30 patients who completed the protocol.

Compared with placebo, Optison did not result in any clinically relevant increases in mean pulmonary artery systolic pressure or pulmonary vascular resistance -- regardless of pulmonary artery systolic pressure at baseline -- and did not induce any serious adverse events.

"Based partially on the results of the present study, the FDA recently amended the product label for Optison to remove the previous requirement of hemodynamic monitoring for 30 minutes after Optison administration in patients with 'unstable cardiopulmonary conditions' or pulmonary hypertension," the authors wrote.

Heart Attack Risk Varies Among Ethnic Minorities

People from ethnic minority groups in the Netherlands had rates of acute myocardial infarction (MI) that were significantly different from those in the majority Dutch population, although the disparity lessened over generations, according to a study in the International Journal of Cardiology.

Using national registries, Louise van Oeffelen, MSc, of University Medical Center Utrecht, and colleagues found that some ethnic groups had lower rates of acute MI compared with the majority population. People from the Philippines had the lowest (hazard ratio 0.40, 95% CI 0.22-0.74) while Pakistanis had the highest (HR 2.04, 95% CI 1.62-2.55). Most ethnic groups had similar or lower rates, however.

The researchers also found that rates of acute MI varied among ethnic groups from the same geographic region. Among groups from North Africa and the Mediterranean, for example, Turkish people had higher rates compared with the majority population and Moroccans had lower rates.

For the most part, acute MI rates either remained similar to or converged toward those in the majority population over multiple generations.

"Healthcare professionals and policy makers should be aware of substantial acute MI incidence differences between minority groups and the majority population, and the often unbeneficial change over generations," the authors wrote. "Future research should be cautious when clustering minority groups based on geographical region of the country of origin."

Use of Cardio Drugs Rises, But Disparities Remain

In another Dutch study, use of cardiovascular medications increased over a 13-year period, although women continued to have lower rates of treatments compared with men.

Carla Koopman, MSc, of University Medical Center Utrecht, and colleagues examined data on use of cardiovascular therapies from 1998 to 2010 using the PHARMO database, which links drug-dispensing records and hospital discharges. The study included about 1.2 million people eligible for primary prevention, 84,621 hospitalized for an acute coronary syndrome, and 15,651 eligible for secondary prevention.

For all three groups of patients, women had lower treatment rates compared with men. Among those taking drugs for primary prevention, for example, women were less likely to be taking lipid-lowering medications for the last 8 years of the study period (5.7% versus 7.3% in 2010) and tended to start taking cardiovascular medications at a later age. The findings were similar in the other two groups of patients.

In contrast to the sex differences, age disparities in drug use tended to become smaller over time.

"Effective primary prevention and secondary prevention have the capacity to quickly lower the burden of coronary heart disease, which makes optimal implementation of cardiovascular drugs in all age and gender groups highly relevant and a necessary and desirable objective," the authors wrote in the European Heart Journal.

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